Effect of the Transcranial Direct Current Stimulation (tDCS) on Dependent Smoking People

Tobacco Abuse Smoke Clinical Trial

— TabaSCo  

Official title:

Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02867514
• Other study ID #: P/2012/133
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 16, 2016
• Start date: March 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Emmanuel Haffen, Prof
• Phone: +33381219007
• Email: emmanuel.haffen[@]univ-fcomte.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also evaluated 1 month post-treatment.

Description:

Tobacco is the second leading cause of death worldwide. It is currently responsible for the death of one in 10 adults (about 5 million deaths per year) and it is the fourth disease risk factor in the world. Many methods to quit smoking are available but in all cases, relapse is a common phenomena. The main risk factor for relapse is craving. So, acting on the craving seems essential to modulate tobacco consumption. Many functional neuroimaging studies have established a neuroanatomical substrate for craving process, in particularly dorsolateral prefrontal cortex (DLPFC), accessible par neuromodulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Fagerström score = 5

• Q-MAT score = 6

• smoking subjects from 10 to 30 cigarettes a day

• right-handed subjects

• w/o severe progressive somatic pathology (especially tumor diseases, degenerative diseases)

• Hamilton Depression Rating Scale-17 score <18

Exclusion Criteria:

• pregnancy and/or lactation

• presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Abuse Smoke
• Tobacco Use Disorder

Intervention

Device:
• transcranial Direct Current Stimulation (tDCS)
After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 1 session per day during 10 days (5 days per week during 2 successive weeks). Subjects will be monitored during tDCS for any side effects or adverse events.

Locations

Country	Name	City	State
France	CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)	Besancon
France	Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in craving evaluated by item 1 of Fagerström test	before and after the 10 sessions	baseline, day 10 and 1 month post-ttt	No